Breast Cancer
Conditions
Keywords
Radiofrequency, Percutaneous technique, breast cancer, tolerance
Brief summary
To determine the efficacy and tolerance of ultrasonography (US)-guided percutaneous radiofrequency (RF) ablation with endocrine therapy in elderly patients with breast cancer who decline or are not candidates for surgery.
Detailed description
There is increasing demand for minimally invasive treatments for small breast malignancies. This is due in part to increased availability of improved treatment approaches, with the introduction of neoadjuvant strategies, and for cosmetic reasons. Moreover, with the introduction of breast cancer screening programs, tumors are frequently diagnosed earlier and at a smaller size, enabling breast-conserving treatment with lumpectomy followed by whole-breast radiation therapy. For elderly patients, however, various physiologic alterations, comorbid diseases, and higher risk of complications are often perceived as contraindications to breast-conserving methods). In addition, elderly cancer patients generally receive fewer surgeries than younger patients. In this context, radiofrequency (RF) ablation is emerging as a minimally invasive nonsurgical technique for the treatment of small breast malignancies. Several pilot studies have published RF ablation tolerance and feasibility results for patients of all ages with small breast cancers and for small cohorts of elderly patients, but there is a lack of prospective data on long-term follow- up and long-term efficacy for elderly patients. In this prospective, single-arm study, we aimed to determine the efficacy and patient tolerance of ultrasonography (US)-guided percutaneous RF ablation with endocrine therapy for elderly patients with breast cancer who decline or are not candidates for surgery.
Interventions
PROCEDUREultrasonography (US)-guided percutaneous radiofrequency (RF) ablation with endocrine therapy
ultrasonography (US)-guided percutaneous radiofrequency (RF) ablation with endocrine therapy
Sponsors
Institut Bergonié
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
In this prospective, single-arm study, we aimed to determine the efficacy and patient tolerance of ultrasonography (US)-guided percutaneous RF ablation with endocrine therapy for elderly patients with breast cancer who decline or are not candidates for surgery
Eligibility
Sex/Gender
FEMALE
Age
70 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients more than 70 years old * Breast tumors with estrogen receptors * Non surgical patients * Life expectancy more than 6 months
Exclusion criteria
* Presence of a pace maker * Tumors measuring more than 30 mm on ultrasound evaluation, located less than 10 mm from skin, nipple, or pectoral muscle * Coagulation disorders * Contra indications to magnetic resonance imaging or computed tomography with contrast medium injection * Non visible lesions on magnetic resonance imaging or computed tomography with contrast medium injection
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Disease Recurrence One Year After the Intervention. | one year | The intervention was ultrasonography (US)-guided percutaneous radiofrequency (RF) ablation with endocrine therapy. Recurrence was assessed based on follow-up with dynamic contrast material-enhanced (DCE) magnetic resonance (MR) imaging). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Disease Recurrence at 5 Years | 5 years after the intervention | The intervention was ultrasonography (US)-guided percutaneous radiofrequency (RF) ablation with endocrine therapy. Recurrence was assessed based on follow-up with dynamic contrast material-enhanced (DCE) magnetic resonance (MR) imaging). |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| US-RF + Endocrine Therapy ultrasonography (US)-guided percutaneous radiofrequency (RF) ablation with endocrine therapy
ultrasonography (US)-guided percutaneous radiofrequency (RF) ablation with endocrine therapy: ultrasonography (US)-guided percutaneous radiofrequency (RF) ablation with endocrine therapy | 21 |
| Total | 21 |
Baseline characteristics
| Characteristic | US-RF + Endocrine Therapy | — |
|---|---|---|
| Age, Continuous | 79 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment France | 21 participants | — |
| Sex: Female, Male Female | 21 Participants | — |
| Sex: Female, Male Male | 0 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 4 / 21 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Number of Participants With Disease Recurrence One Year After the Intervention.
The intervention was ultrasonography (US)-guided percutaneous radiofrequency (RF) ablation with endocrine therapy. Recurrence was assessed based on follow-up with dynamic contrast material-enhanced (DCE) magnetic resonance (MR) imaging).
Time frame: one year
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| US-RF + Endocrine Therapy | Number of Participants With Disease Recurrence One Year After the Intervention. | 1 Participants |
Secondary
Number of Participants With Disease Recurrence at 5 Years
The intervention was ultrasonography (US)-guided percutaneous radiofrequency (RF) ablation with endocrine therapy. Recurrence was assessed based on follow-up with dynamic contrast material-enhanced (DCE) magnetic resonance (MR) imaging).
Time frame: 5 years after the intervention
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| US-RF + Endocrine Therapy | Number of Participants With Disease Recurrence at 5 Years | 4 Participants |